1,709 recalls · Class III, newest first
Reason Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Reason Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Reason Labeling: Missing label
Reason Discoloration; Product may not meet specifications for color description once reconstituted.
Reason Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Reason Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Reason Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
Reason Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Reason Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Reason Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Reason Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Reason Subpotent Drug
Reason Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Reason Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Reason Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Reason Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Reason Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Reason Defective Container: Product lacks tamper evident breakaway band on cap.
Reason Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Reason Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Reason Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.